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FDA Updates

News

FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
News
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
07/24/2024
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug...
07/24/2024
Psych Congress Network
FDA building sign
News
FDA Declines to Approve OX124 Nasal Spray for Opioid Overdose Treatment
07/23/2024
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug...
07/23/2024
Psych Congress Network
lab work
News
Dosing Starts in Pharmacokinetics Study of AD04 for Alcohol Use Disorder
07/08/2024
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of...
07/08/2024
Psych Congress Network
Video Game Treatment for Adults With ADHD Cleared by FDA
News
Video Game Treatment for Adults With ADHD Cleared by FDA
07/02/2024
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults...
07/02/2024
Psych Congress Network
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
News
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
06/11/2024
Evi Arthur
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma,...
06/11/2024
Psych Congress Network
FDA
News
FDA Advisory Committee Rejects First MDMA Treatment for PTSD
06/06/2024
Meagan Thistle
FDA committee rejected an MDMA-based therapy for adult PTSD treatment due to concerns about its effectiveness and the reliability of the data, despite positive study results.
FDA committee rejected an MDMA-based therapy for adult PTSD treatment due to concerns about its effectiveness and the reliability of the data, despite positive study results.
FDA committee rejected an...
06/06/2024
Psych Congress Network
: FDA Approves Oral Valbenazine Granule Formulation, an Alternative Administration Option for Adults With TD
News
FDA Approves Oral Valbenazine Granule Formulation, an Alternative Administration Option for Adults With TD
05/15/2024
Evi Arthur
At the end of April, Neurocrine Biosciences, Inc. announced the approval of INGREZZA® SPRINKLE (valbenazine) capsules by the FDA. This approval provides an alternative option for patients with dysphagia or who have difficulty swallowing. 
At the end of April, Neurocrine Biosciences, Inc. announced the approval of INGREZZA® SPRINKLE (valbenazine) capsules by the FDA. This approval provides an alternative option for patients with dysphagia or who have difficulty swallowing. 
At the end of April, Neurocrine...
05/15/2024
Psych Congress Network
FDA approval stamp
News
FDA Approves First Prescription Digital Therapeutic for Adjunctive Major Depressive Disorder Treatment
04/30/2024
Meagan Thistle
Rejoyn has been FDA approved as the first prescription digital therapeutic for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients.
Rejoyn has been FDA approved as the first prescription digital therapeutic for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients.
Rejoyn has been FDA approved as...
04/30/2024
Psych Congress Network
fda
News
FDA Approves Iloperidone for Acute Treatment of Bipolar I Disorder
04/08/2024
Meagan Thistle
Ilperidone, already approved for acute schizophrenia treatment, received FDA approval on Friday for acute treatment of manic or mixed episodes associated with bipolar I in adults.
Ilperidone, already approved for acute schizophrenia treatment, received FDA approval on Friday for acute treatment of manic or mixed episodes associated with bipolar I in adults.
Ilperidone, already approved for...
04/08/2024
Psych Congress Network
FDA
News
FDA Preliminary Evaluation Finds No Clear Link Between GLP-1 Drugs and Suicidal Thoughts, Cautions on Small Risk
01/26/2024
The FDA's preliminary evaluation of GLP-1 RAs found no evidence that the medications cause suicidal drugs or actions but cautions that a small risk cannot yet be ruled out.
The FDA's preliminary evaluation of GLP-1 RAs found no evidence that the medications cause suicidal drugs or actions but cautions that a small risk cannot yet be ruled out.
The FDA's preliminary evaluation...
01/26/2024
Psych Congress Network
A health care professional reviews paperwork while sitting at a desk in front of a computer
News
Added Remote Support for Antidepressant Discontinuation Offers Only Small Benefits
08/07/2024
Adding internet and phone support to a family practitioner review for possible discontinuation of long-term antidepressants provided small additional benefits.
Adding internet and phone support to a family practitioner review for possible discontinuation of long-term antidepressants provided small additional benefits.
Adding internet and phone...
08/07/2024
Psych Congress Network
Meta-Analysis Characterizes Neural Activation Differences in ADHD and ASD
News
Meta-Analysis Characterizes Neural Activation Differences in ADHD and ASD
08/05/2024
A meta-analysis of 243 studies found both similar and different neural activations during task completion in participants with ADHD and ASD compared with typically developing control subjects. Researchers published their findings in the...
A meta-analysis of 243 studies found both similar and different neural activations during task completion in participants with ADHD and ASD compared with typically developing control subjects. Researchers published their findings in the...
A meta-analysis of 243 studies...
08/05/2024
Psych Congress Network
nursing home care
News
CYP2D6-Metabolized Opioids and Antidepressant Concomitant Use Increases Adverse Events in Nursing Home Residents
08/02/2024
Recent findings have shed light on the potential risks associated with the simultaneous use of CYP2D6-metabolized opioids alongside CYP2D6-inhibiting (as opposed to CYP2D6-neutral) antidepressants among older nursing home residents.
Recent findings have shed light on the potential risks associated with the simultaneous use of CYP2D6-metabolized opioids alongside CYP2D6-inhibiting (as opposed to CYP2D6-neutral) antidepressants among older nursing home residents.
Recent findings have shed light...
08/02/2024
Psych Congress Network
A brain puzzle against an orange background
News
Most Patients With Schizophrenia Relapse-Free With Paliperidone Palmitate, Open Label Extension Study Finds
08/01/2024
In a 2-year open-label extension study of a 1-year randomized clinical trial, 95.6% of the participating patients with schizophrenia being treated with paliperidone palmitate (PP) remained relapse free for up to 3 years.
In a 2-year open-label extension study of a 1-year randomized clinical trial, 95.6% of the participating patients with schizophrenia being treated with paliperidone palmitate (PP) remained relapse free for up to 3 years.
In a 2-year open-label extension...
08/01/2024
Psych Congress Network
Doctor and patient
News
Clinician-Level Differences Significantly Affect MDD Prescribing, Outcomes
08/01/2024
Antidepressant prescribing patterns and outcomes for patients with MDD vary significantly between prescriber groups, suggest study findings published in JAMA Psychiatry.
Antidepressant prescribing patterns and outcomes for patients with MDD vary significantly between prescriber groups, suggest study findings published in JAMA Psychiatry.
Antidepressant prescribing...
08/01/2024
Psych Congress Network
Continuing ADHD Treatment During Pregnancy May Help Patients Better Manage OUD
News
Continuing ADHD Treatment During Pregnancy May Help Patients Better Manage OUD
07/31/2024
Pregnant patients with comorbid ADHD and OUD who remain on their ADHD medications throughout pregnancy are more likely to adhere to OUD treatment and less likely to overdose than patients who stop taking ADHD medication, according to results...
Pregnant patients with comorbid ADHD and OUD who remain on their ADHD medications throughout pregnancy are more likely to adhere to OUD treatment and less likely to overdose than patients who stop taking ADHD medication, according to results...
Pregnant patients with comorbid...
07/31/2024
Psych Congress Network
Secondary Analysis Shows Which Patients With TRD Benefit Most From Ketamine
News
Secondary Analysis Shows Which Patients With TRD Benefit Most From Ketamine
07/24/2024
Ketamine was associated with greater treatment response than electroconvulsive therapy in patients with nonpsychotic treatment-resistant depression who had moderately severe or severe pretreatment symptoms and who initiated treatment as...
Ketamine was associated with greater treatment response than electroconvulsive therapy in patients with nonpsychotic treatment-resistant depression who had moderately severe or severe pretreatment symptoms and who initiated treatment as...
Ketamine was associated with...
07/24/2024
Psych Congress Network
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
News
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
07/24/2024
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug...
07/24/2024
Psych Congress Network
FDA building sign
News
FDA Declines to Approve OX124 Nasal Spray for Opioid Overdose Treatment
07/23/2024
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug...
07/23/2024
Psych Congress Network
One in 7 Patients Experience Antidepressant Discontinuation Symptoms, Study Says
News
One in 7 Patients Experience Antidepressant Discontinuation Symptoms, Study Says
07/22/2024
Including non-specific effects, approximately 15% or 1 in 6 to 7 patients experience antidepressant discontinuation symptoms, according to recent systematic review and meta-analysis results published in The Lancet Psychiatry. 
Including non-specific effects, approximately 15% or 1 in 6 to 7 patients experience antidepressant discontinuation symptoms, according to recent systematic review and meta-analysis results published in The Lancet Psychiatry. 
Including non-specific effects,...
07/22/2024
Psych Congress Network

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Exclusives

andrew penn
Videos
Decoding the FDA Committee's Decision to Reject MDMA-Assisted Therapy: Part 2
07/01/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
07/01/2024
Psych Congress Network
andrew penn
Videos
Decoding the FDA Committee's Decision to Reject MDMA-Assisted Therapy With Andrew Penn, MS, PMHNP
06/21/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
06/21/2024
Psych Congress Network
Nishi Bhopal, MD
Q&As
Dispelling Common Misconceptions About Sleep Medicine
08/08/2024
Nishi Bhopal, MD, clarifies 5 common misconceptions about sleep medicine for mental health care practice.
Nishi Bhopal, MD, clarifies 5 common misconceptions about sleep medicine for mental health care practice.
Nishi Bhopal, MD, clarifies 5...
08/08/2024
Psych Congress Network
Julie Carbray, PhD, APRN
Videos
Can ADHD be properly evaluated and treated via telehealth?
08/06/2024
In this video, Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, offers practical guidance for telehealth providers screening for, diagnosing, and treating attention-deficit/hyperactivity disorder (ADHD) in pediatric and/or adult patients. 
In this video, Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, offers practical guidance for telehealth providers screening for, diagnosing, and treating attention-deficit/hyperactivity disorder (ADHD) in pediatric and/or adult patients. 
In this video, Julie Carbray,...
08/06/2024
Psych Congress Network
Julie Carbray, PhD
Videos
Unraveling the Diagnosis: Differentiating Between ADHD and Bipolar Disorder
08/06/2024
Join Julie Carbray, PhD, APRN, clinical professor of psychiatry and nursing at the University of Illinois Chicago, as she delves into the best practices for diagnosing attention-deficit/hyperactivity disorder (ADHD) and bipolar disorder.
Join Julie Carbray, PhD, APRN, clinical professor of psychiatry and nursing at the University of Illinois Chicago, as she delves into the best practices for diagnosing attention-deficit/hyperactivity disorder (ADHD) and bipolar disorder.
Join Julie Carbray, PhD, APRN,...
08/06/2024
Psych Congress Network
Julie Carbray, PhD
Videos
Updates in Bipolar Disorder Treatment
07/31/2024
Join Dr Julie Carbray as she delves into the recent advancements and emerging therapies in bipolar disorder treatment.
Join Dr Julie Carbray as she delves into the recent advancements and emerging therapies in bipolar disorder treatment.
Join Dr Julie Carbray as she...
07/31/2024
Psych Congress Network
marc agronin md
Blog
Alzheimer Disease Prevention: Part 2
07/29/2024
In this highly anticipated sequel to his 2022 blog, Marc Agronin, MD, geriatric psychiatry section editor at Psych Congress Network, offers deeper expert clinical insights on Alzheimer disease prevention.
In this highly anticipated sequel to his 2022 blog, Marc Agronin, MD, geriatric psychiatry section editor at Psych Congress Network, offers deeper expert clinical insights on Alzheimer disease prevention.
In this highly anticipated...
07/29/2024
Psych Congress Network
Nishi Bhopal, MD
Q&As
The Importance of Sleep Education for Mental Health Clinicians
07/16/2024
Nishi Bhopal, MD, discusses how mental health clinicians can more closely incorporate sleep disorder screening, diagnosis, and treatment into their practices.
Nishi Bhopal, MD, discusses how mental health clinicians can more closely incorporate sleep disorder screening, diagnosis, and treatment into their practices.
Nishi Bhopal, MD, discusses how...
07/16/2024
Psych Congress Network
Amber Hoberg, MSN, APRN, PMHNP-BC
Videos
Comparing VMAT-2 Inhibitor Options for Tardive Dyskinesia Treatment
07/15/2024
Amber Hoberg, MSN, APRN, PMHNP-BC, discusses the key clinical differences between the 2 FDA-approved treatment options for tardive dyskinesia.
Amber Hoberg, MSN, APRN, PMHNP-BC, discusses the key clinical differences between the 2 FDA-approved treatment options for tardive dyskinesia.
Amber Hoberg, MSN, APRN,...
07/15/2024
Psych Congress Network
Amber Hoberg, MSN, APRN, PMHNP-BC
Videos
Comparing VMAT-2 Inhibitor Options for Tardive Dyskinesia Treatment
07/15/2024
Amber Hoberg, MSN, APRN, PMHNP-BC, discusses the key clinical differences between the 2 FDA-approved treatment options for tardive dyskinesia.
Amber Hoberg, MSN, APRN, PMHNP-BC, discusses the key clinical differences between the 2 FDA-approved treatment options for tardive dyskinesia.
Amber Hoberg, MSN, APRN,...
07/15/2024
Psych Congress Network
hoberg
Videos
Tardive Dyskinesia Refresher: Causes, Identification, and Impact
07/10/2024
Refresh your clinical toolbox with information on TD's impact on patients and the essential requirements for successful treatment.
Refresh your clinical toolbox with information on TD's impact on patients and the essential requirements for successful treatment.
Refresh your clinical toolbox...
07/10/2024
Psych Congress Network

Refresher Quizzes

FDA
Quiz
What were the FDA's preliminary findings after investigating GLP-1 RAs?
04/25/2024
Do you remember this FDA update?
Do you remember this FDA update?
Do you remember this FDA update?
04/25/2024
Psych Congress Network
quiz
Quiz
What role does norepinephrine play in bipolar disorder symptom presentation?
08/07/2024
In bipolar disorder, how do norepinephrine (also referred to as noradrenaline) levels impact episodes of mania? Take the quiz!
In bipolar disorder, how do norepinephrine (also referred to as noradrenaline) levels impact episodes of mania? Take the quiz!
In bipolar disorder, how do...
08/07/2024
Psych Congress Network
Three illustrated faces, one sad, one neutral, one happy, with a human hand picking up the happy face
Expert Insights Quiz
HIPPA Considerations for Social Media
07/22/2024
Hone your telehealth practice and knowledge with this quiz!
Hone your telehealth practice and knowledge with this quiz!
Hone your telehealth practice...
07/22/2024
Psych Congress Network
How many symptoms must be present in order to diagnose adult ADHD?
Quiz
How many symptoms must be present in order to diagnose adult ADHD?
07/17/2024
Challenge your diagnostic knowledge!
Challenge your diagnostic knowledge!
Challenge your diagnostic...
07/17/2024
Psych Congress Network
How easy is it to switch patients from olanzapine to olanzapine samidorphan?
Quiz
How easy is it to switch patients from olanzapine to olanzapine samidorphan?
07/16/2024
Do you remember this insight from Dr Jain?
Do you remember this insight from Dr Jain?
Do you remember this insight...
07/16/2024
Psych Congress Network
quiz
Quiz
Percentage of Patients With Major or Mild Frontotemporal NCD Found With Alzheimer Disease Pathology at Autopsy
07/11/2024
What percentage of patients presenting with a syndrome suggestive of major or mild frontotemporal neurocognitive disorder (NCD) are found at autopsy to have Alzheimer disease pathology, according to the DSM-5-TR?
What percentage of patients presenting with a syndrome suggestive of major or mild frontotemporal neurocognitive disorder (NCD) are found at autopsy to have Alzheimer disease pathology, according to the DSM-5-TR?
What percentage of patients...
07/11/2024
Psych Congress Network
A cartoon illustration of a brain with two medical professionals standing on either side; one holds up a magnifying glass to the brain
Quiz
Differences in ADHD Symptoms Due to Sex
07/02/2024
Do you know what the DSM-5-TR says on this topic? Find out with this quiz!
Do you know what the DSM-5-TR says on this topic? Find out with this quiz!
Do you know what the DSM-5-TR...
07/02/2024
Psych Congress Network
quiz
Quiz
Which factor is NOT consideration when choosing an antidepressant medication?
06/28/2024
Which factor is NOT a consideration when choosing an antidepressant medication according to the APA's major depressive disorder practice guidelines? Take the quiz to find out!
Which factor is NOT a consideration when choosing an antidepressant medication according to the APA's major depressive disorder practice guidelines? Take the quiz to find out!
Which factor is NOT a...
06/28/2024
Psych Congress Network
quiz
Quiz
Which symptoms of schizophrenia must be present to make a diagnosis?
06/21/2024
Two of the 5 characteristic symptoms of schizophrenia must be present for a diagnosis to be made. At least one of these must be which of the following, according to the DSM-5-TR? Take the quiz!
Two of the 5 characteristic symptoms of schizophrenia must be present for a diagnosis to be made. At least one of these must be which of the following, according to the DSM-5-TR? Take the quiz!
Two of the 5 characteristic...
06/21/2024
Psych Congress Network
an illustrated head in profile with brain, against a pink background.
Quiz
DSM-5-TR: Opioid-Induced Mental Disorders
06/18/2024
Put your OUD knowledge to the test with this quiz!
Put your OUD knowledge to the test with this quiz!
Put your OUD knowledge to the...
06/18/2024
Psych Congress Network
Can stimulant use increase risk of heart damage in young adults with ADHD?
Quiz
Can stimulant use increase risk of heart damage in young adults with ADHD?
06/17/2024
Time for a pop quiz!
Time for a pop quiz!
Time for a pop quiz!
06/17/2024
Psych Congress Network

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NEW FROM THE NP INSTITUTE ONLINE LEARNING HUB

andrew and julie
Rapid Refresh
Navigating Bipolar Disorder Treatment: Exploring the Role of Second-Generation Antipsychotics
04/11/2024

Featuring Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN

Featuring Andrew Penn, MS, PMHNP, and...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and...
04/11/2024
Psych Congress NP Institute
Amber Hoberg
Rapid Refresh
Long-Acting Injectables for Adolescents With Schizophrenia and Schizoaffective Disorder
04/10/2024
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC,...
04/10/2024
Psych Congress NP Institute
Hoberg and Matthews
Clinical Pearls
Tolerability Testing in Long-Acting Injectable Prescriptions
04/03/2024
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for...
04/03/2024
Psych Congress NP Institute

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